Repetitive Transcranial Magnetic Stimulation (rTMS) for Tinnitus - Full Text View

Sponsored by:	UMC Utrecht
Information provided by:	UMC Utrecht
ClinicalTrials.gov Identifier:	NCT00668720

Purpose

Tinnitus is a phantom auditory perception of meaningless sound, meaning that there is registration of sound in the absence of an external or internal acoustic stimulus. It is a common problem (prevalence 7-19%) which may interfere with the ability to lead a normal life. Unfortunately, it is a very difficult symptom to treat because there are hardly any therapeutic options for the cause of tinnitus. Most therapies focus on alleviating the condition rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Repetitive Transcranial magnetic stimulation (rTMS) is a therapy, based on this concept of reorganization in the auditory cortex. It uses a pulsed magnetic field to disrupt the neural circuit and to thereby (temporarily) excite or inhibit certain brain areas, leading to the suppression of tinnitus.

Condition	Intervention
Tinnitus	Device: transcranial magnetic stimulation (Magstim rapid2) Device: sham stimulation

MedlinePlus related topics: Tinnitus Toe Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Chronic Tinnitus

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:

Tinnitus severity with the Tinnitus Questionnaire [ Time Frame: after treatment, 1 week, 1, 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tinnitus Handicap Inventory [ Time Frame: after treatment, 1 week, 1, 3 and 6 months ] [ Designated as safety issue: No ]
Beck Depression Inventory [ Time Frame: after treatment, 1 week, 1, 3 and 6 months ] [ Designated as safety issue: No ]
State Trait Anxiety Index [ Time Frame: after treatment, 1 week, 1, 3 and 6 months ] [ Designated as safety issue: No ]
Visual Analog Scales on burden, loudness, pitch, presence, and variability of tinnitus and specific problems. [ Time Frame: for the first three months daily and for the second three months monthly ] [ Designated as safety issue: No ]
Audiometry and tinnitus analysis (character match, pitch match, loudness match, minimal masking level, residual inhibition) [ Time Frame: 1 week after treatment and after 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	52
Study Start Date:	April 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Device: transcranial magnetic stimulation (Magstim rapid2) Neuronavigated rTMS will be applied bilaterally to the auditory cortices, which will be identified through a structural MRI scan. Stimulation will be performed with 1 Hz frequency and an intensity of 110% motor threshold for 2000 stimuli (32 minutes) on each side, on five subsequent days.
2: Sham Comparator	Device: sham stimulation The official sham stimulator for the magstim rapid2 will be used. Sham stimulation will follow the same placement protocol and will also last 2x32 minutes on five subsequent days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chronic, non fluctuating, tinnitus, demonstrated by means of the diagnostic Protocol Tinnitus UMCU, of at least two months duration.
Age ≥18 years

Exclusion Criteria:

Treatable cause of the tinnitus
Use of anticonvulsant medication or other psychotherapeutic drugs
History of epilepsy or family members with epilepsy
Presence of active migraine
Presence of psychiatric, severe internal or heart diseases or other neurologic diseases besides epilepsy
Metal objects in and around body that can not be removed
Pregnancy (will be tested on the first day of rTMS using a urine pregnancy test)
Alcohol or drug abuse
Prior treatment with TMS

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668720

Contacts

Contact: Carlijn EL Hoekstra, MD	31-88-755-3606	c.e.l.hoekstra@umcutrecht.nl
Contact: Bert A van Zanten, AuD	31-88-755-3702	g.a.vanzanten@umcutrecht.nl

Locations

Netherlands
University Medical Center Utrecht	Recruiting
Utrecht, Netherlands, 3584 CX
Principal Investigator: Carlijn EL Hoekstra, MD

Sponsors and Collaborators

UMC Utrecht

Investigators

Principal Investigator:

Bert A van Zanten, AuD

Dept. of Otorhinolaryngology, University Medical Center Utrecht

More Information

Responsible Party:	Department of Otorhinolaryngology, University Medical Center Utrecht ( dr. G.A. van Zanten )
Study ID Numbers:	rTMS_tinnitus_Utrecht
Study First Received:	April 25, 2008
Last Updated:	April 25, 2008
ClinicalTrials.gov Identifier:	NCT00668720
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:

tinnitus
transcranial magnetic stimulation

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Otorhinolaryngologic Diseases

Neurologic Manifestations
Ear Diseases
Tinnitus

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009